GSK announces EAGLE-1 phase III trial met primary efficacy endpoint

GSK announced positive headline results from the EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea in adolescents and adults. The trial met its primary efficacy endpoint, with gepotidacin demonstrating non-inferiority to intramuscular ceftriaxone plus oral azithromycin, a leading combination treatment regimen for gonorrhoea. The result is based on a primary endpoint of microbiological response at the Test-of-Cure visit 3-7 days after treatment. Chris Corsico, Senior Vice President, Development, GSK, said: “With rising incidence rates and concern around growing resistance to existing treatments, gonorrhoea poses a threat to public health globally. These positive headline results demonstrate the potential for gepotidacin to provide a novel oral treatment option in the face of rising resistance and for patients who cannot take other treatments due to allergies or intolerance.” The safety and tolerability profile of gepotidacin in the EAGLE-1 phase III trial was consistent with results seen in gepotidacin phase I and II trials.